Efficacy and Safety of IQP-VV-102 in Weight Management

Obesity Clinical Trial

Official title:

Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-VV-102 in Reducing Body Weight in Overweight and Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681069
• Other study ID #: INQ/009712
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2012
• Last updated: October 5, 2015
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: October 2015
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the subjects' body weight, body fat and safety parameters are monitored

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18 to 60 years

• 25 kg/m2 = BMI = 35 kg/m2

• Written informed consent

Exclusion Criteria:

• Known sensitivity to sources of the active ingredients and excipients

• Pregnancy or nursing

• Inability to comply with study requirements, e.g. due to language difficulties

• Participation in another study during the last 30 days of the screening visit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• IQP-VV-102

Other:
• Placebo

Locations

Country	Name	City	State
Germany	Barbara Grube	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight at End of Study Compared to Baseline	Change in body weight at the end of study compared to baseline	12 weeks	No
Secondary	Change in Waist Circumference (in cm) at End of Study From Baseline	Difference in waist circumference (in cm) at end of study from baseline	12 weeks	No
Secondary	Change in Mean Body Fat at End of Study From Baseline	Measured in kg using calibrated weighing scales	12 weeks	No